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Trial record 6 of 6 for:    "Gastric Cancer" | "Dexmedetomidine"

A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil

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ClinicalTrials.gov Identifier: NCT01920113
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but it is limited to use alone. The investigators designed this study to compare the effect and safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.

Condition or disease Intervention/treatment Phase
Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection Drug: Dexmedetomidine - remifentanil group Drug: Propofol - remifentanil group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : October 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: DR group
In Group DR, a bolus dose of 0.5mcg/kg dexmedetomidine was injected intravenously 5 minutes before the start of the procedure (Precedex®, Abbott, Istanbul, Turkey). And a continuous infusion dose of 0.3-0.7mcg/hr/kg was started.
Drug: Dexmedetomidine - remifentanil group
Active Comparator: PR group
In Group PR, a bolus injection of 1 mg/kg of propofol was followed by a continuous infusion at a rate of 3-5mg/hr/kg(Pofol®, Dongkook Pharm. Co. Ltd., Seoul, Korea) using an infusion pump (Syringe Pump TE-331, Terumo Japan).
Drug: Propofol - remifentanil group



Primary Outcome Measures :
  1. A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil [ Time Frame: right after the drugs had administered ]

    Safety : whether the complications as follows occur or not

    1. systolic blood pressure under 90mmHg or 20% out of range of the baseline SBP
    2. heart rate under 50bpm
    3. oxygen saturation under 90%, respiratory rate under 7 per minute


Secondary Outcome Measures :
  1. A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil [ Time Frame: right after the drugs had administered ]

    Efficacy :

    1. whether a bolus injection of 10 mg of propofol was administered or not
    2. evaluating the depth of sedation using MOAA/S scale all through the procedure
    3. whether the en bloc resection, complete resection were done or not under the sedation


Other Outcome Measures:
  1. A comparison of patient's satisfaction during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil [ Time Frame: within 24hrs after procedure ]
    Patients' satisfaction : investigate in four steps questionaire (very good, good, bearable and unbearable) when the patients' were discharged from PACU

  2. A comparison of gastric motility, easiness for procedure, operator's satisfaction during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil [ Time Frame: right after the drugs had administered ]
    Subjects' motility grading during procedure, easiness of procedure, operator's satisfaction : investigate in four steps questionaires by the operator after the procedure



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥20
  • American Society of Anaesthesiologists(ASA) physical status classification I~III
  • Early gastric cancer patients who were scheduled for Endoscopic submucosal dissection

Exclusion Criteria:

  • Age < 20
  • American Society of Anaesthesiologists(ASA) physical status classification IV
  • those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
  • known drug allergies or history of drug abuse
  • psychological disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920113


Locations
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Korea, Republic of
Anesthesiology & Pain Medicine, Yonsei university college of medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01920113     History of Changes
Other Study ID Numbers: 4-2012-0621
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Yonsei University:
Endoscopic submucosal dissection
propofol
remifentanil
dexmedetomidine
efficacy
safeness

Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics